Adjustable Tensioning Device

ABSTRACT

An adjustable tensioning device capable of providing and holding high tensions needed for medical devices, prosthetics, and orthotics.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a child application of and relies on thedisclosures of and claims priority to and the benefit of the filingdates of the following, and the disclosures of the followingapplications and other applications/patents/literature cited herein arehereby incorporated by reference herein in their entirety:

U.S. patent application Ser. No. 17/902,683, filed Sep. 2, 2022,

U.S. patent application Ser. No. 17/864,675, filed Jul. 14, 2022,

U.S. patent application Ser. No. 17/700,479, filed Mar. 21, 2022,

U.S. patent application Ser. No. 17/537,476, filed Nov. 29, 2021,

U.S. patent application Ser. Nos. 17/211,590 and 17/211,635 filed Mar.24, 2021,

U.S. patent application Ser. Nos. 17/074,571 and 17/074,542, filed Oct.19, 2020,

U.S. patent application Ser. No. 15/585,968, filed May 3, 2017,

U.S. Provisional Patent Application No. 62/331,315 filed on May 3, 2016,

PCT Application No. PCT/US2020/047904, filed Aug. 26, 2020,

PCT Application No. PCT/US2022/021822, filed Mar. 24, 2022, and

U.S. Provisional Patent Application No. 63/394,530, filed Aug. 2, 2022.

BACKGROUND OF THE INVENTION Field of the Invention

The current invention comprises a tensioning device capable of hightensions needed for medical prosthetics and orthotics, as describedherein.

Description of Related Art

Dial tensioning systems are used for apparel and sports equipment toadjust the fit of the equipment to the wearer. Dial tensioning systemsmade by BOA Technologies of Colorado, USA; YOW Systems of the YouNingTechnology Company located in Shenzhen, China; FitGo Technology locatedin Shenzhen, China; UTurn located in Soeborg, Denmark; and Fidlock Gmbhlocated in Hannover, Germany, are used on snowboarding boots, bicyclesafety helmets, and athletic shoes, for example. In such examples, alace connects two opposing elements of the apparel. Turning the dialtensioning system draws the two opposing elements closer togetherthereby tightening the apparel to the wearer's body. Such systems aredescribed in the prior art as “closure systems,” “closure device[s],” or“lacing systems,” which are fundamentally different functionally fromthe current invention to a high-torque tensioning device for adjustingforces around, across, or between a joint or body part.

The amount of tension that the dial must produce in these examples isrelatively low. For example, the spring constant of common elasticathletic shoelaces made by LockLaces was measured to be 0.8 lbs/in. Itis reasonable that the amount of tension needed to secure footwear isabout 1-2 lbs. of tension.

A study on the Twisting Force of Aged Consumers When Opening a Jarpublished in the journal of Applied Ergonomics in February 2002,recommends a torque of ˜18 in-lbs. or less for consumers 50 to 94 yearsof age. A table of torque guidelines for bottle caps published onhttps://www.kinexcappers.com/faq/torque-guidelines.htm recommends atorque of 10-18 in-lbs. for caps ˜1″ in diameter. This is roughly thesame magnitude for the tension needed to secure footwear.

In practice this means that dial tensioning systems for foot wear do notrequire large torque multipliers. An average user has enough wriststrength to tighten footwear by turning a dial with a 1:1 torquemultiplier. Moderate torque multiplying methods—for example, designingthe dial with a larger diameter than the winding shaft—are sufficientfor many apparel applications.

The BOA Technologies website lists four different basic dialplatforms—the H-series, the M-series, the S-series, and the L-series—ofwhich three series do not employ a torque multiplier system (other thanthe dial/shaft diameter difference mentioned above). FitGo lists 17different dial styles on their website within the L2 Series, the M5Series, the L7 Series, and the L8 Series. None of the FitGo dials employa torque multiplier system (other than the dial/shaft diameterdifference). Likewise, neither FidLock nor YOW Systems offer torquemultiplier systems on any of their models (other than the dial/shaftdiameter difference.)

The BOA Technologies H4 dial style uses a planetary gear multipliersystem which contributes approximately a 4:1 mechanical advantage.However, the anti-unspooling feature used in the H4 dial is a series ofbackwards angled dogs at roughly a 45 degree angle. The H4 dial isreleased by pulling the dial upwards which disengages the dial from thedogs. As the tension on the dial is increased, the resulting forcepressing the dial into the body of the dial tensioning elementincreases. That is, for every pound of winding tension about 0.7 lbs. offorce presses the dial into the body of the H4 dial tensioning device.For typical footwear tensions, this means the user would need to pullthe dial upwards with ˜0.7-1.4 lbs. to release it. As the amount oftension that is applied by the BOA H4 dial tensioning system increases,the force needed to pull up the dial to release it also increases. Itfollows that beyond a certain point, the force needed to release thedial will exceed the average hand strength of the user. This isespecially a problem for elderly users.

For applications where the total tension is (relatively) low and wherethe user population is young and fit (e.g., sports equipment users),this design limitation is not an issue. For other applications thatrequire relatively high tensions, an older population of users, and/orusers with a medical condition that affects strength or agility, thedesign tradeoffs of the BOA H4 is not a currently adequate solution, aproblem which is resolved by the current invention.

Furthermore, it should be considered that lower limb orthotic andprosthetic devices support significant amounts of weight in the range ofhundreds of pounds per limb. Existing tensioning devices do not providethe strength and durability required to reliably support these forcesneeded to assist gait, immobilize a joint, or replace the normalfunction of muscles, tendons and ligaments.

SUMMARY OF THE INVENTION

In embodiments, the current invention is to a rotary tensioning deviceespecially for, in some cases, medical devices, prosthetics andorthotics, the device capable of producing and holding high tensions,easy to use for elderly or infirm users, and having the release forceremain relatively constant no matter how much tension is applied. Such adevice would be suitable for generating or moderating forces across,between, or along components of medical, prosthetic or orthotic devices,to produce the relatively large forces needed for limb, joint and muscletreatment.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts an embodiment of an adjustable tensioning deviceaccording to the invention described herein.

FIGS. 2 a, 2 b, 2 c, and 2 d depict aspects of an embodiment of anadjustable tensioning device according to the invention describedherein.

FIGS. 3 a and 3 b depict aspects of an embodiment of an adjustabletensioning device according to the invention described herein.

FIGS. 4 a and 4 b depict aspects of an embodiment of an adjustabletensioning device according to the invention described herein.

FIGS. 5 a and 5 b depict aspects of an embodiment of an adjustabletensioning device according to the invention described herein.

FIGS. 6 a and 6 b depict aspects of an embodiment of an adjustabletensioning device according to the invention described herein.

FIGS. 7 a and 7 b depict aspects of an embodiment of an adjustabletensioning device according to the invention described herein.

FIGS. 8 a and 8 b depict aspects of an embodiment of an adjustabletensioning device according to the invention described herein.

FIGS. 9 a and 9 b depict aspects of an embodiment of an adjustabletensioning device according to the invention described herein.

FIG. 10 depicts an aspect of an embodiment of an adjustable tensioningdevice according to the invention described herein.

FIG. 11 depicts an aspect of an embodiment of an adjustable tensioningdevice according to the invention described herein.

FIG. 12 depicts an aspect of an embodiment of an adjustable tensioningdevice according to the invention described herein.

FIG. 13 depicts an aspect of an embodiment of an adjustable tensioningdevice according to the invention described herein.

FIG. 14 depicts an embodiment of an adjustable tensioning deviceaccording to the invention described herein.

FIG. 15 depicts an embodiment of an adjustable tensioning deviceaccording to the invention described herein.

FIG. 16 depicts an embodiment of an adjustable tensioning deviceaccording to the invention described herein.

FIG. 17 depicts an embodiment of an adjustable tensioning deviceaccording to the invention described herein.

FIG. 18 depicts an embodiment of an adjustable tensioning deviceaccording to the invention described herein.

FIG. 19 is a chart showing various aspects of the invention as describedherein.

FIG. 20 depicts an embodiment of an adjustable tensioning deviceaccording to the invention described herein.

FIG. 21 depicts an embodiment of an adjustable tensioning deviceaccording to the invention described herein.

FIG. 22 depicts an embodiment of an adjustable tensioning deviceaccording to the invention described herein.

FIG. 23 depicts a medical device (e.g., orthotic) including anembodiment of an adjustable tensioning device according to the inventiondescribed herein.

FIG. 24 depicts an embodiment of an adjustable tensioning deviceaccording to the invention described herein.

FIG. 25 depicts an embodiment of an adjustable tensioning deviceaccording to the invention described herein.

FIGS. 26 a, 26 b, 26 c, and 26 d depict aspects of an embodiment of anadjustable tensioning device according to the invention describedherein.

FIG. 27 depicts an embodiment of an adjustable tensioning deviceaccording to the invention described herein.

DETAILED DESCRIPTION OF THE INVENTION

The present invention has been described with reference to particularembodiments having various features. It will be apparent to thoseskilled in the art that various modifications and variations can be madein the practice of the present invention without departing from thescope or spirit of the invention. One skilled in the art will recognizethat these features may be used singularly or in any combination basedon the requirements and specifications of a given application or design.Embodiments comprising various features may also consist of or consistessentially of those various features. Other embodiments of theinvention will be apparent to those skilled in the art fromconsideration of the specification and practice of the invention. Thedescription of the invention provided is merely exemplary in nature and,thus, variations that do not depart from the essence of the inventionare intended to be within the scope of the invention.

All references cited in this specification are hereby incorporated byreference in their entireties.

In embodiments, the current invention comprises a tensioning devicecapable of high tensions needed for medical prosthetics and orthotics,as described herein, which can have several sub-elements: an anchor andsocket, a spool and tension element, a clutch, an anti-unspoolingmechanism, a torque multiplier system, and a dial. (“High tension,” inaspects, can mean more than 100 lbs. of tension on the tension elementwrapped around the spool. In other aspects, it can mean more than 50lbs., more than 60 lbs., more than 70 lbs, and so on and so forth.) Someof the elements described herein may be sub-mechanisms with severalmoving pieces. In aspects, various elements or the functions of theelements may be combined to simplify the assembly of the tensioningdevice.

FIG. 1 shows an exploded view of a typical configuration of theinvention described herein. The dial (10) snaps onto the anchor (14) andcaptures the release button (11) and the sun gear drive element (12) ofthe torque multiplier system (16). The sun gear (13) is embedded in thedrive element (12). The planetary gears (15) are connected to the spool(17) and engage in corresponding teeth not visible in the anchor ring(14). The anchor ring (14) twists and locks into the socket (18). Thetensioning element is not shown in FIG. 1 . The clutch as describedabove is combined into the connection mechanism between the button (11)and the drive element (12). The anti-unspooling mechanism as describedabove is obtained by the interaction of the arms disposed around theanchor (14) and recesses disposed along the inner surface of the dial(not visible). The torque multiplier system example of FIG. 1 comprisestwo systems: a planetary gear drive which comprises the spool (17) whichacts as the carriage of a planetary gear drive, planetary gears (15),the sun gear (13), and the inner ring gear (not visible in the interiorof the anchor ring) (14); and the torque multiplier difference betweenthe diameter of the dial (10) and the diameter of the shaft of the spool(17). “Tension element” as used herein can include cables, cords,braids, string, lace, thread, rope, and the like, as well as the variouscombinations of flexible, substantially non-elastic material that can bewrapped around the spool. “Tension element” or “tensioning element” asused herein can further include an energy storage element as describedherein.

Spool and Tension Element

In embodiments, the first end of the tension element can be connected tothe element of the orthotic or prosthetic that requires tensioning. Thesecond end of the tension element can be connected to the spool. Inaspects, another element of the orthotic may require tensioning. Asecond tension element may be employed to connect this second element tothe spool. Alternatively, a single tension element connects the twoorthotic elements and passes through or is attached to the spool suchthat as tension element is collected on the spool, both orthoticelements are tensioned. In another aspect, a second end of the tensionelement is attached to a non-tensioning element of an orthotic (forexample, an anchoring element) and passes through or is attached to thespool. In aspects described above, as the spool is rotated it winds thetension element around itself.

The dimensions of the spool can, in aspects, affect the performance ofthe tensioning device. The channel or receptacle in the spool thatgathers the tension element needs to be large enough to hold all thetension element that needs to be wound. The size of the channel orreceptacle depends on the diameter of the tension element, the lengththat will be wound, and/or the number of tension elements connected tothe spool. A thinner diameter tension element is advantageous, inaspects, because a longer length of tension element can be collected inthe channel or receptacle. On the other hand, a thinner diameter tensionelement typically has less tensile strength than a thicker diametertension element. In addition, a thinner diameter tension element can cutinto the spool at high tensions. Suitable tension element materials anddiameters for the tensioning device described herein can be, in aspects,ultra-high molecular weight polyethylene (UHMWPE), polyester, Kevlar,aircraft cable, and the like, between, by way of example, 0.5 mm and 3mm in diameter.

In embodiments, the diameter of the spool can define or determine thedepth of the channel or receptacle. A deeper channel, that is—a smallerspool diameter—can store more of the tension element. In addition, asmall diameter spool combined with a large diameter dial adds to thetorque multiplier effect. However, as the spool diameter gets smaller,the tension on the tension element can cut into the spool materialthereby causing failure. Experimental trials of commercially availablespools made of polypropylene with a diameter of 14 mm failed when thetension was applied to a UHMWPE tension element with a diameter of 1.2mm. In another trial of several, the tension element cut through thespool at 160 lbs. of tension; in yet another trial, the tension elementcut through the spool at 200 lbs. of tension. Experiments of spools madeof 3D printed nylon 12 were able to withstand tension element tensionsof 200 lbs. without failure when the spool diameter was 18 mm orgreater.

FIG. 2 a shows a typical spool (20) suitable for winding the tensionelement (not shown) of the present invention. There is an upper flange(21) and a lower flange (22) that help capture the tension element as itwinds around the shaft (23) to prevent it from tangling. In FIG. 2 a ,two holes (25) are positioned through the center of the shaft to be usedto secure the tension element to the spool. A fillet (24) is provided tooppose the tendency of the tension element from cutting into the spool.FIG. 2 b shows another version of a typical spool (20′). The height ofthe shaft (23′) and the size of the fillet (24′) is such that the topand bottom fillets blend into each other for maximum resistance tocutting of the tension element. The dual holes (25) to secure thetension element shown in FIG. 2 a have been replaced by a single oblonghole (25′) in FIG. 2 b which may be wide enough to accept two or moretension elements side by side.

In aspects, the spool can be reinforced to resist cutting by the tensionelement with another material (or materials) that has (or have) greatercutting resistance than the spool material itself. For example, theshaft of the spool made of polypropylene could be reinforced with asleeve of ultra high molecular weight polyethylene, glass reinforcednylon, an epoxy/carbon fiber composite, metal tubing, a ceramic, aglass, various combinations therein, or the like. In this manner, theadvantageous toughness, light weight, low cost, and shock resistance ofpolypropylene could be employed in the body of the spool whileincreasing the cutting resistance of the spool by the tensioning elementat the surfaces of reinforcement. Other geometries of the reinforcingmaterial, such as a dowel pin, could be used in conjunction with or inplace of a sleeve.

FIG. 2 c is a sectional view of the spool in 2 b. FIG. 2 d is asectional view of a spool variant that shows the location of areinforcing sleeve (27).

FIG. 3 a is an illustration of a spool variant with an integratedplanetary gear drive carriage (30). The carriage (30) is connected andintegral with the top flange (21). The shaft (23) is reinforced withfour dowel pins (32). In this variant, the feature to secure the tensionelement (25) is hole through the shaft with an offset passage (33)extending all the way through the bottom flange (22). FIG. 3 b is abottom view of the spool in FIG. 3 a . The location of the dowel pins(32) are clearly shown. The path of the hole (25) through the shaft isshown by dashed lines in FIG. 3 b . In other words, as shown in FIG. 3 ,the spool includes a spool shaft, a bottom flange, and a top flange,wherein one or more reinforcement structures are located within thespool and oriented perpendicular to the bottom flange and the op flangeand parallel to the spool shaft.

Example #1

A spool with a shaft diameter of 14 mm was 3D printed out of nylon 12.The total height of the spool was 9 mm. 25 mm diameter flanges, 2 mm(thick) capped the ends of the spool to retain the wound tensionelement. Four holes 3 mm in diameter were formed through the entirespool from flange to flange. The distance from the center of the holesto the center of the spool was 6 mm. Four 9 mm long stainless steeldowel pins 3 mm in diameter were pressed into the holes. A portion ofthe cylindrical outer surface of the dowel pins protruded from thesurface of the shaft. A tensioning element 1.2 mm in diameter made ofUHMWPE was wound around the spool at 200 lbs of tension and then thetension was released. This was repeated ten times. At the termination ofthe trial, no cutting was observed on the shaft of the spool.

Attaching the tension element (or tension elements) to the spool can beaccomplished by providing a hole (or holes) through the spool. The holeneeds to be larger than the diameter of the tension element so thetension element can pass through it. If the diameter of the hole is toobig it will reduce the strength of the spool and make it prone tocutting under tension. Fillets and chamfers can help prevent cutting ofthe tension element.

A method of attaching the tension element to the spool is to pass itthrough the hole and tie a knot in the end. The knot must be largeenough so that it does not squeeze through the hole when the tensionelement is under tension, such as high tension. Thus, a large diameterhole to accommodate a variety of tension element diameters from 0.5 to 3mm (for example) can make it difficult to secure smaller diametertension elements by using a knot on one end.

A passage or slot (33) can be cut into the spool from one flangeextending to the middle of the channel or receptacle such as shown inFIGS. 3 a and 3 b . Such a passage removes the need for threading thetensioning element though a hole aiding in the assembly of the orthotic.The slot can be a direct connection to the main tensioning element path(25), or it can be offset from the path to create a connected yetsecuring path for the tensioning element to prevent it from accidentallydetaching from the spool.

Example #2

A spool 3D printed from nylon 12 with a diameter of 20 mm, a channelheight of 4 mm, flanges 2 mm thick and 25 mm in diameter, was testedwith 1.2 UHMWPE tension element. A passage 1.5 mm wide extended from thebottom flange into the spool 4 mm. A 2 mm cylinder was cut into thepassage through the spool. Up to 1 meter of tension element could bewound on the spool. The spool was wound until tension on the tensionelement reached 200 lbs. Slight markings by the tension element werenoted, but no damage was observed when the tension was released and thetension element unwound.

Clutch

In embodiments, a functional preference of the tensioning device is thatit be able to apply tension to the tension element, hold it securely,and release the tension (preferably easily release the tension). Thetension can be applied by turning the dial. The tension can be held bymeans of the anti-unspooling mechanism (or elements). The clutch can beused to couple the spool to the anti-unspooling mechanism. In apreferred embodiment, when the clutch is engaged, the spool cannotunwind. In a preferred embodiment, when the clutch is disengaged, thespool unwinds (such as freely unwinds) thereby releasing the tension.

In embodiments, the clutch of the invention described herein has twointermeshing pieces. In one embodiment, the first clutch elementcomprises a plurality of protrusions that intermesh/engage with aplurality of recesses in the second clutch element. In anotherembodiment, the first clutch element comprises a plurality ofprotrusions that intermesh/engage with a plurality of protrusions on thesecond clutch element. The first clutch element can be attached, fixed,or built into the upper flange of the spool. The second clutch elementcan be attached, fixed, or built into the anti-unspooling mechanism orthe torque multiplier system.

The clutch geometry can be predominately planar, cone shaped, orcylindrical. When the clutch is predominantly planer, the intermeshingelements protrude (or are sunk) from the surface (into the surface) ofthe first clutch element. Corresponding intermeshing elements are sunk(or protrude) into the surface (from the surface) of the second clutchelement.

FIG. 4 a is an illustration of one embodiment of a predominately planarclutch (40) with twelve identical intermeshing element features. Eachfeature has a leading edge (42) and a trailing edge (44). FIG. 4 b is anillustration of the mating clutch piece for the one shown in FIG. 4 a .In this example, the second clutch piece is built into a dial (46).There are twelve intermeshing element features that mate with thefeatures shown in FIG. 4 a . Each intermeshing feature in FIG. 4 b has aleading edge (42′) and a trailing edge (44′).

FIG. 5 a is an illustration of one embodiment of a predominantly coneshaped clutch (50) with eight identical intermeshing element features.Each feature has a leading edge (52) and a trailing edge (54). The firstclutch piece (50) is integrally attached to a spline feature (56) whichallows the clutch piece to securely engage with dial tensioning devicein both an upwards and a downwards position. In the upward position thefirst clutch piece (50) engages with a corresponding second clutch piece(57) that is shown in FIG. 5 b as integrally attached to a dial (58).There are eight identical intermeshing element features in the secondclutch piece each with a leading edge (52′) and a trailing edge (54′).

FIG. 6 a is an illustration of one embodiment of a predominatelycylindrical clutch (60) with eight identical intermeshing elementfeatures (e.g., protrusions). Each feature has a leading edge (orprotrusion face) (62) and a trailing edge (64). FIG. 6 b shows thecorresponding second clutch piece (67) having recesses that mate withthe protrusions of the first clutch piece shown in FIG. 6 a . The secondclutch piece is integrally attached to a release button (66). There areeight identical intermeshing elements each with a leading edge (62′) anda trailing edge (64′). The trailing edges (64) and (64′) are designed sothat when the second clutch piece (67) is position downwards of thefirst clutch piece (60) (the disengaged mode) the intermeshing featuresare able to easily self-align so that the second clutch piece can moveupwards (into the engaged mode). In the engaged mode, the leading edges(62) and (62′) of the intermeshing elements are aligned and are fully ornearly fully in contact with each other. The splines (68) enable therelease button (66) to securely engage with the dial tensioning devicein both the upward (engaged) and lower (disengaged) positions.

Force is transmitted from the first clutch piece to the second clutchpiece when the intermeshing elements of the first clutch piece pressagainst the intermeshing elements of the second clutch piece. Thecontact surface of the first intermeshing elements with the secondintermeshing elements can be planar, curvilinear, or combinations of thetwo. The contact surface can be normal to the force vector from thefirst clutch piece to the second clutch piece.

In aspects, the contact surface can be at an angle to the force vector.FIG. 7 a shows a substantially planar first clutch piece (70) withtwelve identical intermeshing element features, each with a leading edge(72) and a trailing edge (74). The leading edge (72) has a 20 degreeback angle.

In aspects where the surface is at an angle to the tensioning forcevector, the force vector can be resolved into a force normal to theintermeshing element surface and a force tangential to the intermeshingelement surface. FIG. 7 b shows a force diagram of the tensioning forceon a schematic of the leading edge (72) of the first clutch piece. Thetensioning force, F, has been resolved into two orthogonal forces: F_(N)which is normal to the surface of the leading edge and F_(T) which istangential to the surface of the leading edge. When there is atangential force vector, the tangential forces may act to drive thefirst clutch element into the second clutch element. Such a tangentialforce would advantageously help keep the first clutch element engagedsecurely with the second clutch element but may disadvantageously hinderthe willful separation of the first clutch piece from the second clutchpiece. Conversely, the tangential force can work to disengage the firstclutch piece from the second clutch piece either prematurely (for a poordesign) or upon reaching a predetermined maximum force (for aself-limiting clutch).

Ideally, the intermeshing elements' surfaces would not slide anddisengage in an unwanted manner when a force is applied from the firstclutch piece to the second clutch piece. Similarly, the force topurposely disengage the clutch pieces would be constant and notdetermined by the amount of tension applied by the tensioning element.Adding notches, roughness, dimples, contours and the like to thesurfaces of the intermeshing elements can be used to help reduceunwanted disengagement of the first and second clutch pieces.

FIG. 8 a is an illustration of one embodiment of a substantially planarclutch piece (80) with six identical intermeshing element features eachwith a leading edge (82) and a trailing edge (84). The leading edge asshown is curvilinear and provides more contact surface area with thecorresponding second clutch piece (not shown). FIG. 8 b is anillustration of another embodiment of a substantially planar clutchpiece (85) with six identical intermeshing element features each with aleading edge (86) and a trailing edge (88). The trailing edge in FIG. 8b is depicted as a chamfer (as opposed to the filleted trailing edge inFIG. 8 a ). Both fillets and chamfers on the trailing edges help thefirst and second clutch pieces to self-align when moving from adisengaged to engaged position. A dimple (87) is shown on eachintermeshing element feature which is designed to fit with acorresponding recess in the second clutch piece (not shown).

The portions of the clutch pieces upon which the intermeshing elementsare attached should not flex excessively when a force is applied fromthe first clutch piece to the second clutch piece. If the clutch piececan flex too much, the angle between the intermeshing element surfacenormal and the force vector may increase to the point where thetangential force vector catastrophically disengages the first and secondclutch pieces.

A predominately cone shaped clutch piece and a predominatelycylindrically shaped clutch piece are less prone to flexing than apredominately planar clutch piece. However, cone shaped andcylindrically shaped clutch pieces are taller than planar clutch piecesand may not be as desirable when a compact clutch is desirable.

Flexing can be countered by reinforcing the clutch piece with a stiffmaterial such as a composite, glass, ceramic, or metal. Likewise wear ofthe sliding faces of the intermeshing element surfaces can be reduced byreinforcing, coating, or impregnating the surfaces with suitablematerials.

Example #3

A predominately or substantially planar first clutch piece was 3Dprinted from nylon 12 and incorporated into the upper flange of a spool.The diameter of the first clutch piece was 25 mm. Twelve wedge elementsprotruded from the upper flange spaced equally around the circumferenceof the spool flange. Each wedge was 2 mm tall with a 15 degree arc inthe circumferential direction. A 25 degree draft was incorporated on thetrailing face of the 12 wedges. (In this example, the counterclockwisedirection of the wedge was the trailing face.) The leading face of allthe wedges were 90 degrees from the plane of the upper flange surface.

A second clutch piece was 3D printed from nylon 12. The second clutchpiece had a face that was the geometrical reciprocal of the first clutchpiece face. (In this application, ‘geometric reciprocal’ is defined asthe boolean combination of two geometries where one geometry is removedfrom the other geometry. Thus, where the wedges protruded from the spoolflange in the first clutch piece, a corresponding wedge shape was cutout of the face of the second clutch piece.) A 0.5 mm relief was cutfrom the trailing draft faces of the second clutch piece wedges toenable the first clutch piece and the second clutch piece to nest.

A spring with 4 lbs. of compression strength pressed on the bottom faceof the spool thereby forcing the first clutch piece to engage with thesecond clutch piece.

A tension element was attached to the spool and the spool was wound in aclockwise direction to increase the tension on the tension element. Thetension on the tension element was measured. When the tension elementtension exceeded 120 lbs. of tension, the first clutch piece disengagedfrom the second clutch piece causing the spool to unwind.

Example #4

A spool was 3D printed from nylon 12 with an 18 mm diameter, 25 mmdiameter flanges, where the spool channel was 5 mm tall and each flangewas 1 mm tall. A first clutch piece was 3D printed into the upper flangeface. The first clutch piece was 25 mm in diameter. Twelve wedges werespaced equally, radially around the circumference. The wedges were 2 mmtall with a 15 degree arc length. The trailing edge of each wedge wasgiven a 25 degree draft. The front edge of each wedge was 90 degreesfrom the face of the flange.

A second clutch piece was 3D printed from nylon 12. The second clutchpiece was the geometrical reciprocal of the first clutch piece. A 0.5 mmrelief was cut from the trailing draft faces of the second clutch piecewedges to enable the first clutch piece and the second clutch piece tonest.

When the spool was wound, generating a tension on the element tensionof >100 lbs., the upper flange of the spool broke at the stressconcentration corner of one of the first clutch piece wedges.

Example #5

A predominately cylindrical first clutch piece was 3D printed from nylon12. The outer diameter was 12 mm with an inner diameter of 10 mm and aheight of 7 mm. Eight intermeshing elements 2.5 mm longcircumferentially by 1.5 mm long radially by 3 mm tall were arrangeduniformly around the top outer edge of the cylinder. The bottom,trailing edges of each intermeshing element was fileted with a 3 mmradius.

A second cylindrical clutch piece was 3D printed from nylon 12. Theouter diameter was 20 mm with an inner diameter of 18 mm. Eightintermeshing elements 1.5 long radially and 3 mm tall were arrangeduniformly along the bottom inner edge of the cylinder. The top, trailingedges of each intermeshing element was fileted with a 3 mm radius.

The intermeshing elements were fully engaged when the bottom edge of thesecond clutch piece was 3 mm below the top edge of the first clutchpiece. A spring with a compression force of 10 lbs at full compressionwas placed between the first and second clutch pieces.

Torque applied to the second clutch piece was transmitted via aplanetary gear system to a spool via the first clutch piece. Differentvalues of tension were applied to the tension element wrapped around thespool and the force to slide the second clutch piece down to disengageit from the first clutch piece. FIG. 19 shows a graph of the force todisengage the clutch versus the tension applied to the spool. The trendline in FIG. 19 is generally flat with the majority of the values lyingbetween 4 and 8 lbs. This result is surprisingly advantageous because itmeans that the force needed to allow the spool to unwind does notincrease dramatically with the amount of tension applied to the tensionelement. Also, the magnitude of the force is low which means that thisclutch mechanism is very suitable for applications for the elderly,infirm, children, or injured people.

In addition, the release motion of the clutch in this example was adownward push. Pushing a button, dial, or boss is preferred as a releasemechanism for a dial tensioning device compared to pulling. Pulling adial (for example) requires grasping strength that may be beyond thecapabilities of the elderly, infirm, children, or injured people. Thispush-button release also solves problems with currently availableon-market technologies that are likely to jam and fail.

The clutch pieces of the previous example were held in the properengaged position by means of a spring and the appropriate stops in theconnected elements that limited the travel of the clutch pieces. Analternative or additional method to position the clutch pieces in adesired position is by the use of magnets. FIG. 20 is an illustration ofthe use of magnets to control the clutch positioning in a dialtensioning device.

The dial (200) has six interior spline slots that mate with the sixsplines on the exterior of the release button (202) which acts as thesecond clutch piece. The first clutch piece (204) is connected to thesun gear (205). The anchor ring (206), one embodiment of an anchoringelement, comprises the flexible arms of the anti-unspooling mechanism(the mating recesses are located on the inner wall of the dial and arenot visible in this view). The anchor ring also comprises the ring gearof the planetary gear system. The spool (208) acts as the carriage ofthe planetary gear system and supports the four identical planetarygears (209). There is a first set of six recesses (203) positioned insplines of the release button (202). These recesses are sized to hold arare earth magnet. There is a second set of six more recesses (201)positioned in the slots in the dial into which the release buttonsplines slide. The recesses (201) are also sized to hold a rare earthmagnet or a suitable ferromagnetic element. The positions of the secondset of recesses in the dial and the first set of recesses in the releasebutton are situated such that the attraction of magnets in one set ofrecesses to magnets or ferromagnetic materials in the other set ofrecesses aligns the release button into the engaged clutch position.

Alternatively, magnets could be placed inside the release button (202)and inside the first clutch piece (204) and oriented to repulse eachother to push the second clutch piece into the engaged position with thefirst clutch piece.

Example #6

A dial tensioning device with the components illustrated in FIG. 20 was3D printed from nylon 12. Twelve 2×5 mm rare earth magnets were fit andglued into the first and second set of recesses as shown in FIG. 20 .The magnets were oriented so that the magnets in the first set wereattracted to magnets in the second set. The haptic feel of the releasebutton when it was depressed to disengage the clutch was satisfying.

Anti-Unspooling Mechanism

In a preferred embodiment, the dial is turned clockwise to increase thetension element tension. Without an anti-unspooling mechanism, the spoolwould unwind the tension element once the user released the dial. Theanti-unspooling mechanism should allow the user to turn the dial toincrease the tension element tension but prevent unwinding even at hightension element tensions.

Pivoting pawls, flexible arms, dogs, cams, roller clutches, spragclutches, and worm gears are all methods of providing one-directionrotation. Worm gears, cams, roller clutches, and sprag clutches can benearly silent in operation and are preferred for situations whichrequire noiseless operation (e.g., for the use in medical orthotics tobe used in the field by the military). Flexible arms and dogs have theadvantage of being simple mechanisms that function well in the presenceof dirt and grit.

FIGS. 9 a and 9 b show examples of parts that comprise ananti-unspooling mechanism: a ring of flexible arms (90) and an array ofcorresponding recesses (90′). FIG. 9 a shows the flexible arms integralwith an anchor ring (94). There are eight identical flexible arms (91)of a generally curved shape. Each arm has a distal end (92) that isshaped to engage securely in one of the forty corresponding recesses(95) shown in FIG. 9 b . The bases of the flexible arms (91) areconnected to a ring (93) which is connected to the anchor ring (94). InFIG. 9 b the array of recesses (95) are shown integral with a dial (inthis example the dial and the array of recesses (90′) are the same).

FIG. 10 is an enlargement of a single flexible arm (100) shown in FIG. 9a . Flexible arms have a height, h, and a length approximately describedby the double headed arrow in FIG. 10 . The cross-sectional area, A, maybe uniform or may vary along the length of the flexible arm. The distalend or the tip of the flexible arm (102) mates with a correspondingrecess or flat. The tip may be designed to fit into a single recess orflat, or multiple recesses or flats. The distal end of a pivoting pawl,flexible arm, or dog, can engage in a recess or flat of an opposingelement. More than one pawl, flexible arm or dog can be employed toincrease the resistance of the anti-unspooling mechanism to tensionelement tension. The pawls, arms, or dogs may be equally spaced radiallyor distributed in a pattern. In a preferred embodiment, all the distalends of the pawls, arms, or dogs contact the opposing recesses or flatsat the same time. That is, if there are 24 recesses or flats equallyspaced circumferentially, it is preferred that there are 2, 3, 4, 6, 8,or 12 pawls, arms, or dogs equally spaced circumferentially so that thedistal ends contact the recesses or flats at the same time.

The number of recesses and distribution of the pawls, arms, or dogs, candetermine the amount the dial can unwind before the anti-unspoolingmechanism catches and prevents unspooling. It is advantageous that theanti-unspooling mechanism prevents unspooling before, in an embodiment,at most 1/10th of unwind rotation occurs (that is, the anti-unspoolingmechanism should prevent the dial from unwinding more than 36 degreeswhen the user releases the wind tension on the dial). Excessiveunwinding makes it difficult for the user to apply the desired level oftension and is counter-intuitive which can lead the user to believe theanti-unspooling mechanism is not functioning properly. Increasing thenumber of recesses in the mating receiver will decrease the amount ofunwinding before the anti-unspooling mechanism catches. However,increasing the number of recesses also decreases the maximum size of therecesses. This can be overcome somewhat by configuring the end of thepawl, flexible arm, or dog to engage multiple recesses at the same time.There is balance between the minimum number of recesses to preventunacceptable unwinding and the maximum number of recesses before therecess geometry becomes ineffective at holding the pawl, flexible arm,or dog from unwinding.

A pawl, flexible arm, or dog can be modeled as a cantilevered beam. Thecompression strength of a pawl, flexible arm, or dog (that is, theability to withstand the unspooling tension of the tension element) canbe increased by selecting a material of higher young's modulus, thealtering shape of the element (for example, to increase thecross-sectional area at one or more cross-sections along the element),and/or increasing the height of the element. All of these options willincrease the bending resistance of a flexible arm, but increasing theheight of the flexible arm increases it the least compared to the othertwo options. Thus, to retain ease of turning the dial in the tighteningdirection, it is preferred to increase the height of the flexible arm.

High flexing resistance can make the anti-unspooling mechanism difficultto turn in tightening direction and can result in a loud, unpleasant‘click’ as the pawls, arm, or dogs flex into the recesses in the matingreceiving ring. In addition, a high flexing resistance can cause unduewear of the pawl, flexible arm, or dog tip and/or the recess featuresleading to premature failure. In a preferred embodiment, it is desirablethat the anti-unspooling mechanism turns quietly and easily in thetightening direction.

Example #7

Two flexible arm anti-unspooling mechanisms were 3D printed from nylon12. The design of the arms was similar as shown in Figures A and B. Thefirst example had 4 arms; the second had 6 arms. The correspondingopposing element had 24 recesses 1.5 mm deep. The arms were 5 mm inheight. Both anti-unspooling mechanisms turned easily in the clockwisedirection. The 4 armed element failed when subjected to a 200 lbs.tension element tension on the spool, whereas the 6 armed element wasable to withstand a 200 lbs. tension element tension.

Example #8

15 wedge shaped dogs 2 mm in width and 1.5 mm in height were designedinto the inside surface of a dial which was 3D printed out of nylon 12.The opposing elements were an equal number of reciprocal wedges in thepiece upon which the dial rotated. As the dial was turned, the dogsbumped up over the top of the opposing wedges. When seated into theopposing wedges, the dial prevented a spool from unspooling under atension of approximately 75 lbs.

Changing the length of the pawl, flexible arm, or dog, can also affectthe bending resistance of the element. A longer pawl, flexible arm, ordog will be less stiff and less resistant to bending. In theory, thecompressive strength of a beam is independent of the length of the beam.In practice, a beam will buckle before its compressive strength isexceeded and since the force that causes buckling decreases as the beamlength increases, increasing the pawl, flexible arm, or dog length todecrease the bending resistance can result in a reduction inanti-unspooling strength. Buckling failure of the pawls, arms, or dogscan be reduced by providing side support to the pawl, flexible arm, ordog. In particular, if the pawl, flexible arm, or dog is designed withan inherent curve the direction of buckling can be determined andsupport to the outer side of the pawl, flexible arm, or dog can beprovided.

Example #9

An anti-unspooling mechanism was 3D printed from nylon 12 consisting of4 curved arms 15 mm long, 5 mm tall and approximately 5 mm2 in crosssection. The end of the arms were configured to engage with two notchesin the recesses of the mating ring. Forty recesses 1 mm deep wereequally spaced along the interior wall of the mating ring. Theanti-unspooling mechanism allowed easy turning in the tighteningdirection but withstood >120 in-lbs of torque in the looseningdirection. As unwinding force increased, the arms flexed outwards andwere supported by the mating ring to prevent premature buckling.

A relief can be cut into the pawl, flexible arm, or dog to act as ahinge and decrease the bending resistance. The hinge preferentiallybends in one direction but resists bending in the opposite direction. Inthis manner, the pawl, flexible arm, or dog can have a low bendingresistance but a high anti-unspooling resistance. FIG. 11 shows anotherexample of flexible arm design (111). In this example, each distal tip(112) of the flexible arms are configured to fit into two adjacentrecesses in the corresponding mating element. A curvilinear relief (113)is provided which extends through the height of the flexible arm. Therelief is designed such that the tip of the flexible arm can bendreadily inwards toward the center but it is difficult for the tip tobend outwards away from center. In this manner, the flexible arm canpivot out of the way when the dial (with the corresponding recesses) isrotated in the clockwise direction. When the dial (and correspondingrecesses) is rotated in the counterclockwise direction the arm willresist the rotation thereby providing an anti-unspooling function.

FIG. 12 shows a cross sectional view of yet another example of aflexible arm configuration. Element 121 (the array of recesses) andelement 122 (the array of flexible arms) work together to provide ananti-unspooling feature. The arm lengths (123) in FIG. 12 are nearlytwice as long as the flexible arms (111) depicted in FIG. 11 . The largeaspect ratio (length to cross sectional area) of the flexible arms inFIG. 12 would be subject to buckling at lower forces than the flexiblearms in FIG. 11 . The outward curvature of the flexible arms (123) inFIG. 12 determines the direction of buckling. In the example shown inFIG. 12 , the arms would buckle away from the center of the element 122.The peaks of the recesses (124) end up supporting the arms and hinderthe buckling.

Example #10

An anti-unspooling mechanism was 3D printed from nylon 12. Eight armswere arranged uniformly, circumferentially around the outer perimeter ofthe anti-unspooling mechanism. Each arm was 5 mm tall and approximately12 mm long. A zig-zig recess was cut along the base of each arm. Theanti-unspooling mechanism turned easily in the tightening direction andheld firmly in the unwinding direction and withstood 180 in-lbs ofunwinding torque.

A second device was hooked to a motor and rotated more than 5,000 timesto simulate wear. The force required to unwind the anti-unspoolingmechanism was measured to be 140 in-lbs of torque. The low bendingresistance reduced the wear of the arm/recess features while stillproviding a high unspooling resistance.

In another embodiment, the flexible arms or vanes can be made of metalsuch as spring steel. Recesses can still be utilized to provide anaudible ‘click’ and to provide a detent that defines the increment oftensioning that the dial can provide before unwinding slightly beforethe pawl, flexible arm, or dog engages the recess. However, if themating element is considerably softer than the material of the flexiblearm, the flexible arm can stick into the surface of the mating elementslightly (in effect, creating a recess ‘on the spot’). Ananti-unspooling mechanism made in such a manner could operate silently(without the ‘clicking’ noise from the pawls, arms, or dog settling intoa corresponding recess) and would minimize the amount of unwindingallowed when turning the dial. FIG. 21 is a top view of anti-unspoolingmechanism made with spring steel vanes as the flexible arms. An innercircle (212) has six identical slots arranged around the circumferenceof the piece. Six pieces of spring steel (214) are inserted into theslots to act as vanes or flexible arms. The distal tips (213) of thevanes rub on the inner wall of an outer dial (211). When the dial isrotated clockwise in relation to the inner circle, the vanes dragagainst the inner wall. When the dial is rotated counterclockwise inrelation to the inner circle, the tips of the vanes (213) dig into theinner wall and prevent such rotation.

Example #11

An anti-unspooling mechanism was made by 3D printing a spool/carriagefrom nylon 12. Six slots roughly 1 mm wide and 10 mm long were designedinto the carriage. A portion of 0.008″ thick spring steel was cut into 3mm tall by 12 mm long rectangles. The rectangles were glued into threeof the six slots (leaving the other three slots empty). A dial withforty V-shaped recesses designed into the inner wall was placed over thespool/carriage. The dial could be turned easily in the winding directionbut resisted an unwinding tension of more than 100 lbs on the spool. Theanti-unspooling mechanism can be built into the second piece of theclutch, the torque multiplier system, or the dial element. Incorporatingthe anti-spooling element in proximity to the spool reduces the forcesthat could pitch, tilt, cant, or move the spool out of position.Alternatively, affixing the anti-spooling element to the dial or theinput side of the torque multiplier system reduces the amount of forceon the, for example, flexible arms of the anti-unspooling mechanism.The, for example, flexible arms can be made with a smaller cross-sectionor shorter, which allows them to turn more easily in the tensioningdirection while securely preventing the spool from unwinding under hightension.

Torque Multiplier System

The high tensions required for a medical orthotic or prosthetic (e.g.,in aspects, >200 lbs.) can create a need for a torque multiplier systemof the adjustable tensioning device. A torque multiplier system can bemade designing the diameter of the dial to be larger than the diameterof the spool. However, there is a practical and aesthetic limit to howlarge the selected diameter of the dial can be, and a functional limitto how small the diameter of the spool can be made before tensionelement cutting becomes a failure mechanism. Thus there is a need for atorque multiplier system that can be used in addition to the offset inthe dial and spool diameter.

Examples of torque multiplier systems suitable for a medical orthoticadjustable tensioning device are planetary gear drives, cycloidal geardrives, gear trains, and worm screw/worm gear combinations, and thelike, and combinations thereof. Another method to multiply the force isto select an appropriate path of the tension element itself throughpulleys, rings, guides, and the like, to generate a mechanical advantage(e.g., a block and tackle or the equivalent). In aspects, combinationsof torque multiplication elements such as gear trains, dial/spooldiameter combinations, and tension element path can be used inconjunction.

Planetary gear drives are made of a sun gear, several planetary gears,and a ring gear (sometimes called an ‘internal gear’). A cross-sectionalview of an example of a planetary gear drive (131) is shown in FIG. 13 .Traditionally, the planetary gears (133) are mounted in an elementcalled a carriage (not shown). If the ring gear (132) is fixed (keptfrom turning), rotating the sun gear (134) will cause the carriage toturn. The ratio of rotation of the sun gear versus the rotation of thecarriage is 1 plus the number of teeth in the internal gear divided bythe number of teeth in the sun gear.

For example, for module 1.0 gears, if the sun gear has 10 teeth, itspitch diameter will be around 10 mm. If the planetary gears also have 10teeth, their pitch diameter will also be around 10 mm. The pitchdiameter of the ring gear will be 2*10 mm+10 mm, or 30 mm. The ring gearwill therefore have 30 teeth. The ratio of rotation of the sun gear tothe carriage will be 4:1. Using the planetary gear drive described,applying a torque of 25 lbs. to the dial will result in a torque of 100lbs. to the spool (assuming, for the sake of this example, that thediameter of the dial and spool are the same.)

In aspects, the minimum size of a planetary gear drive is determined bythe diameter of the ring gear. To decrease the size of the planetarygear drive one can reduce the number of teeth in the sun and planetarygears and/or reduce the gear module. There is a practical limit on theminimum number of teeth in a gear; it can lie between 7 and 16 teeth, inexamples. The minimum size for the module of the gear (making the sizeof the teeth smaller) depends on the load applied and the material ofwhich the gear is made. The resolution of current commercial multi jetfusion 3D printers sets a practical limit of about 0.5 module gears.

Increasing the thickness of a spur gear is an effective way ofincreasing the amount of load it can handle. Helical gears are alsostronger than spur gears and have the advantage of gradually contactingthe opposing tooth faces rather than the all-or-nothing contact of atraditional spur gear. Helical gears create a radial force when engagedwhich can be detrimental. Herringbone gears have a net zero radial forcebut are difficult to manufacture using traditional manufacturingmethods.

Example #12

A planetary gear drive was made using a 5 mm tall module and 1.2 gears.The sun gear had 10 teeth. The four planetary gears had 12 teeth. Thering gear had 34 teeth. The gears were 3D printed from nylon 12. The sungear was fabricated into a dial and the carriage holding the planetarygears was connected to a spool. By turning the dial, it was possible toapply a 200 lbs. tension to the tension element wrapped around the spoolwithout any of the gear teeth in the sun gear, planetary gear, or ringgear from failing.

Planetary gear drives can be stacked. Affixing a sun gear to onecarriage can drive a second carriage. In this manner the effective gearratio of the first carriage is multiplied by the effective gear ratio ofthe second carriage. If the correct combinations of sun/planetary gearsizes are selected, the first and second carriage can use a common ringgear.

FIG. 14 shows an exploded view example of a double stacked planetarygear drive. The release button (141) is centered in the dial (142).Disposed on the interior of the dial is a sun gear (not shown) thatengages with the upper carriage (143). Four identical planetary gears(144) are driven by the sun gear in the dial (142). The planetary gears(144) engage in the teeth of the ring gear (148). When the dial isturned, the sun gear drives the upper carriage with a mechanicaladvantage, MA₁, equal to the number of the teeth in the ring gear(T_(R)) divided by the number of teeth in the first sun gear (T_(FS))plus one. A second sun gear (145) is connected to and driven by theupper carriage (143). The second sun gear (145) in turn drives the fouridentical planetary gears (147) of the lower carriage (146). The lowercarriage planetary gears (147) also engage the teeth of the ring gear(148). The mechanical advantage, MA₂, of the lower planetary gear driveis the number of teeth in the ring gear (T_(R)) divided by the number ofthe teeth in the second sun gear (Tss) (145) plus one. There is anadditional mechanical advantage, MA₃, derived from the ratio of thediameter of the dial (142) with the diameter of the spool (149). Thecombined mechanical advantage of the dial tensioning system shown inFIG. 14 is: MA₁×MA₂×MA₃.

Cycloidal gear drives can provide high gear ratios (torque multiplier)in a compact form, such as gear ratios from 10:1 to 300:1. FIG. 15 is anexample of a 6:1 torque multiplier cycloidal drive. A cycloidal gear(151) rides inside a housing (152). There are five identical lobes (153)on the gear and six corresponding recesses (156) in the housing. Anoff-centered drive pin (not shown) engages the cycloidal gear centerhole (154). When the cycloidal gear is rotated by the drive pin one lobeis forced into a recess. Because there is one fewer lobe than there arerecesses, the cycloidal gear completes one revolution for every sixrevolutions of the off-centered drive pin. The output of the cycloidgear can be coupled to another element (not shown) by means of eccentricpins (not shown) that ride in the holes (155).

Example #13

A cycloidal gear drive torque multiplier system was made with a disc of2 mm thickness and 5 lobes. The ring had 5+1 lobe for a torquemultiplication factor of 6:1. An eccentric cam (with an eccentricity of2 mm) was driven by a dial. Under even moderate tension elementtensions, the cam popped out of the disc, in experiments.

Worm screw/worm gear drives can be used where a high torque multiplieris needed. Worm screw/worm gear drives also have the advantage that theycannot be backdriven. That is, a torque applied to the worm gear (theoutput) does not cause the worm screw (the input) to turn. A wormgear/worm screw system can remove the need for the anti-unspoolingmechanism. It can also allow the user to reduce some tension on thetensioning device by unwinding the worm screw without the need tocompletely release all the tension.

FIG. 16 is an illustration of a 6:1 mechanical advantage worm drive. Adial (161) is connected to a worm screw (162). The worm screw as shownhas two thread starts. That is, there are two threads that wrap aroundthe worm screw in a helix offset from each other. The threads of theworm screw engage with the cuts in the worm gear (164). There are twelvecuts along the circumference of the worm gear (6:1 mechanical advantagetimes 2 starts=12 cuts). The advantage of using multiple starts on theworm screw is that more than one thread can be engaged with the wormgear at any given time which improves the ability to transmit hightorques from the worm screw to the worm gear. The worm gear is connectedto a spool (166) via a clutch element (165). The release button (163)rides in a hollow shaft through the worm gear and the clutch element.Pushing on the release button moves the spool (166) to the left as shownin FIG. 16 , which allows the spool to spin freely. Pushing on theengage button (167) re-seats the spool in the clutch element binding itsrotation to the worm gear. Since worm screws cannot be backdriven bytorque on the worm gear, there is no need, in embodiments, for a furtheranti-unspooling mechanism; in other words.

Example #14

A worm screw/worm drive system was generated with a worm screw 25 mm indiameter and a thread pitch of 10 mm. The thread had two starts (thatis, there were two independent threads wrapped around the shaft). A wormgear 12 mm width and 19 mm in diameter was positioned with its axis ofrotation at 90 degrees to that of the worm screw's axis of rotation. Themechanical advantage of the worm screw/worm gear combination was 6:1.Turning the worm screw 6 times causes the worm gear to rotate once. Whenthe worm screw was turned, the threads of the worm screw jumped thecorresponding threads in the worm gear at tension element forces above30 lbs.

Traditional gear trains offer a wide variety of design choices for atorque multiplier system but they may not be as compact as planetary orcycloidal gear trains. They are, however, often simpler to design,manufacture, and assemble than planetary or cycloidal gear trains.Almost any gear ratio desired can be designed using traditional geartrains.

FIG. 17 is an illustration of an example of a typical gear trainsuitable for use in a dial tensioning device. A dial (171) is connectedto a small diameter drive gear (172). The drive gear couples with alarger diameter driven gear (173). The mechanical advantage of thesefirst two gears, MA₁, is determined by dividing the number of teeth (T₂)in the driven gear by the number of teeth in the drive gear (T₁):MA₁=T₂/T₁. A second small diameter drive gear with a number of teeth,T₃, (174) is coupled with the driven gear (173). This second drive gearis coupled with a second large diameter driven gear (175) which has anumber of teeth T₄. The mechanical advantage from these two gears is:MA₂=T₃/T₄. The drive shaft of the dial/first drive gear passes through ahole in the second driven gear. The face width of the first driven gearis larger than the face width of the first drive gear which enables thedial/first drive gear ensemble to slide along the first driven gearwithout disengaging. Pushing on the dial/first driven gear/shaft presseson the face on one of the clutch elements (176) to disengage the spool(177). A spring (not shown) returns the spool to the engaged positionwhen the force pushing the dial down is released. Since ordinary geartrains can be back-driven, an anti-unspooling mechanism(s) would, inembodiments, need to be employed to prevent the spool from unwindingprematurely. The total mechanical advantage of the system shown in FIG.17 is the ratio of the dial diameter (D_(dial)) with the spool shaftdiameter (D_(shaft)) times MA₁ times MA₂.

Example #15

In embodiments, a pulley system is used wherein pulleys generate amechanical advantage. Using this system, one can increment or decrementtension by rotating the dial one way, and loosing by rotating the dialin a second direction. This pulley system can use at least one fixedpulley or anchor point and at least one free or moveable pulley oranchor point, wherein the position of the free pulley will move as thetensioning element is wound and unwound. With this system, themechanical advantage can be changed using different arrangements of theanchor points as well as adjustments of the pulley path. The pulleysystem can act in-between the tensioning line and the rotatable(tension) dial giving the user a mechanical advantage when they increaseor decrease tension.

FIG. 18 is an example of a pulley system (180) derived to provide amechanical advantage for a tensioning system. A frame element (181) isshown in outline. One end of a tension element (183) is anchored at aposition (185) to an internal component (187) of the frame element (forexample, an energy storage element of an orthotic). The tension elementis looped through a ring (182) (or pulley, or the like) that is anchoredto the frame element. The tension element then loops around a secondring (184) (or pulley or the like) that is affixed to the same component(187) where the anchor position (185) terminates. The tension elementthen continues along the direction shown by the arrow in FIG. 18 . Thetension element may be connected to a dial tensioning element, a lever,another pulley system or the like. Pulling on the upper end of thetension element imparts a 2:1 mechanical advantage to the tensionimparted on the internal component (187). In other exemplary embodimentswhere the torque multiplier element is a pulley system, the pulleysystem may be a fixed, movable, compound, or block and tackle pulleysystem. The system may comprise one or more pulleys to yield mechanicaladvantages ranging from 2:1 to 20:1 or greater.

Example #16

A knee orthotic was fabricated using 3D printing from nylon 12. Atensioning dial with a 3:1 mechanical advantage was used. An energystorage element was situated across the hinge elements on both themedial and lateral sides of the orthotic. One of the distal ends of theenergy storage element was anchored to the lower frame. The other distalend of the energy storage element was connected to tensioning dial witha substantially inelastic cable 1.2 mm in diameter made of UHMWPE. Thepath of the cable is shown schematically in FIG. 18 .

Polished steel oblong rings were used as the “pulleys” for the cable toslide upon. The torque multiplier of the cable-pulley system was 2:1.The total torque multiplier of the orthotic was 2:1 of the cable pathtimes 3:1 of the dial for a result of 6:1. The cable-pulley system wasthen routed in such a way to create at 3:1 torque multiplier, andcoupled with a 3:1 dial to spool ratio, resulting in a total mechanicaladvantage of 9, showing, through experimentation, that the system anddevice according to the current invention can be engineered to achievehigher force multipliers by adjusting the dial to spool ratio andcable-pulley mechanical advantage.

A dial tensioning device needs a method to release the tension on thetension element. Dial tensioning devices suitable for apparel and sportssuch as those made by BOA Technologies, YOW Systems, FidLock, and FitGoTechnologies most often use a ‘pull to release’ mechanism. When the userpulls up on the dial, the spool is allowed to turn freely which releasesthe tension on the tension element. A ‘push to release’ mechanism canalso be used to release the tension on a dial tensioning device as shownin FIGS. 1, 14, 16, 17, and 20 .

The ‘push to release’ mechanism can be configured to release only whilethe user is actively pushing the release button. This configuration is asingle stable state system: engaged. (In other words, when the userisn't actively pushing on the release button, the device is engaged bydefault.) Alternatively, a release mechanism can be configured to havetwo stable states: engaged or disengaged. An example of a device withtwo stable states is a ball point pen. Clicking on the cap extends thepen for writing where it remains until the cap is clicked again whereinthe pen retracts. This is known in the art as a “push-push latch”.

FIG. 22 is an illustration of one embodiment of a bi-stable releasebutton. A release button (221) fits into a sleeve (220). The releasebutton serves as the second clutch piece and has eight clutch features(222) arranged on its lower, inner surface. A first clutch piece (223)is integral with a sun gear (224) of a planetary gear system. The firstclutch piece has eight clutch features (225) arranged along its upper,outer surface. Stable state ‘engaged’ occurs when the clutch features(222) and (225) are touching each other. This happens when the releasebutton is at a specific height. Stable stage ‘disengaged’ occurs whenthe clutch features (222) are lower than the clutch features (225). Thishappens when the release button is a second, different height (lowerthan the first). Six bosses (226) are arranged around the upper, outersurface of the release button. The bosses ride in race track grooves(227) cut into the inner surface of the sleeve. A spring (not shown)between the first clutch piece and the second clutch piece pushes therelease button upwards. The race track (227) is designed so that the twostable locations of the bosses (226) correspond to the engaged anddisengaged heights of the clutch features.

Another type of bi-stable release button suitable for a dial tensioningsystem is shown in FIG. 27 . FIG. 27 shows an embodiment of a “push-turnlatch”. The button (270) and the receiving element—in this case theanchor ring (278)—are shown in an exploded view. The button (270) isable to move axially within the dial (not shown for clarity). Eightidentical splines (272) are located circumferentially around the outsideof the button. The splines allow the button to slide axially up and downin corresponding grooves in the dial (not shown) but prevent the buttonfrom rotating freely within the dial. In this manner, torque applied tothe dial is transmitted to the release button (which is in turn anelement of the clutch as described in the configuration shown in FIG. 22). The release button has teeth (274) arranged along the bottom edge.These teeth mate with recesses (276) in the receiving element (278).When the release button is pressed downwards to disengage the clutch asshown by the dashed arrow in FIG. 27 , the lower edge of the buttonteeth forces the button to turn (slightly) counter-clockwise when itcontacts the receiving element. The tabs at the distal ends of the teeth(274) engage in the recesses (276) and prevent the button from poppingup when the user stops pushing the button down. When the user turns thedial clockwise to tighten it, the button also rotates clockwise. Thebutton teeth disengage from the recesses allowing it to pop back up intothe clutch engaged position. In aspects, a dial tensioning deviceincorporating some or all of the elements described above can beconfigured as a modular component that is a fully (or nearly fully)assembled, independent device that is meant to be attached to anotherarticle to be used. In embodiments, such a modular component is fullyfunctional by itself and ready for use after being mounted andconfigured appropriately. For example, in aspects, a dial tensioningdevice that was configured as a modular component would be ready to useafter being mounted on another article (e.g., an orthotic device) andthe tensioning elements affixed to the spool.

Modular components are often manufactured by one party and sold to asecond party who subsequently incorporates the modular component intotheir product. This is the basis of Industry 2.0 where piecework andassembly lines were commonly adopted. In this paradigm, element and partdesigns (that is, the subcomponents of the modular components) areoptimized for the manufacture of the modular component, not necessarilyfor the finished assembly for which the modular component is intended.Industry 3.0 and 4.0 (Digitization and Network) are changing thisparadigm with the adoption of 3D printing which enables embeddedfunctionality.

FIG. 23 is a perspective view of a dial tensioning device embedded in adouble upright dynamically unloading knee brace. The knee brace iscomprised of an upper frame (231), a lower frame (232), and hingeconnection elements (233). The dial tensioning device (234) is embeddeddirectly into the upper frame. The upper frame contributes criticalfunctionality to the dial tensioning device (described below). In asimilar manner, the dial tensioning device contributes criticalfunctionality to the dynamically unloading knee brace orthotic. Thedistinction between the orthotic and the dial tension mechanism blurs inthe embodiment shown in FIG. 23 .

An exploded view of the embedded dial tensioning device in a portion ofa top frame (231) is shown in FIG. 24 . As in FIG. 20 (which is anexample of a modular component dial tensioning device) there are thefunctional equivalents of a dial (247), an anti-unspooling mechanism, aclutch/release element (246, 245, and 244), a spool (242), a torquemultiplier, and a socket (241). The anti-unspooling mechanism comprisesflexible arms (not readily visible under the dial) and the matingrecesses on the socket (241). The clutch element comprises a releasebutton (246) with second clutch pieces arranged internal to the buttoncylinder. A spring (245) maintains the restorative force to keep thebutton in the upper, engaged position. The sun gear drive (244) hasfirst clutch pieces arranged externally around the sun gear drivecylinder. The torque multiplier system comprises the planetary geardrive comprising the sun gear drive (244), four identical planetarygears (243), and a ring gear within the socket (241).

FIG. 25 shows an enlarged side view of the socket (241). Thesocket—which is integral with the upper frame contributes five criticalfunctions to the operation of the dial tension mechanism. First, thereare the mating recesses (251) for the flexible arms of theanti-unspooling mechanism. Second, there is a retaining lip (252) uponwhich the dial clipped and rotates around. Third, there is a recess(253) for the axial boss of the spool which ensures that the spool iscentered and rotates with low friction within the socket. Fourth, thereis a tension element guide (254) that provides a pathway for thetensioning element. Fifth, the ring gear (255) is integrated into thesocket and contributes to the function of the planetary gear drive.

The button and dial of the dial tensioning system are readily visible tothe user and can be configured functionally and aesthetically indifferent ways. The dial may have recesses or grooves to provide asecure grip when the user turns the dial. Additionally, the dial mayhave a rubberized outer surface or surface features to improve the gripwhen, for example, the user's hands are wet. In addition to functionalbenefits, the button and dial may also have branding or ease-of-usebenefits. FIG. 26 a shows an orthogonal view of a dial (260) and button(262). The button in FIG. 26 a is configured with a non-slip surface.FIG. 26 b shows an orthogonal view of a dial (260) and a button (264).The button in FIG. 26 b is configured with instructions on the operationof the button. In FIG. 26 b the marking is recessed into the surface ofthe button. FIG. 26 c shows an orthogonal view of a dial (260) and abutton (266). The button in FIG. 26 c is configured with a corporatename (in this example, the fictional company “Freight on BoardTechnologies”). The markings in FIG. 26 c are raised above the surfaceof the button. FIG. 26 d shows an orthogonal view of a dial (260) and abutton (268). The button in FIG. 26 d is configured with a corporatelogo (in this example, the emblem of Icarus Medical Innovations ofCharlottesville, Va.).

Additional Embodiments

In aspects, the tensioning device may further comprise an energy storageelement to dynamically adjust forces across, between or around a jointor body part in an orthotic or prosthetic device. may contain individualor interconnected energy storage systems, which control forces around,between or within the joint. The tensile or compression force storedwithin the energy storage element is controlled by the tensioning deviceand adjusted by the user as needed. The energy storage element may be atensioning element or a compression element, or both depending onwhether the system is typically under tension or compression during use.In embodiments, the energy storage element may be comprised of elasticbands, springs, liquids (e.g. pneumatic systems) and may also store andrelease energy in compression as well as tension. The energy storageelement may be selected to have specific properties, for example aYoung's Modulus that allows for discrete levels of force to be storedand applied around a given axis of the joint. The energy storage systemmay be connected at one or more points to different regions of theorthosis to direct force around the desired axis. For example, theenergy storage element may run across a hinge or a cam in order togenerate a torque around a joint rather than providing a force betweenthe joint.

In aspects, the tensioning device is capable of changing the force in asubstantially continuous, gradual, incremental, or stepwise manneracross a range or spectrum of magnitudes of force. In aspects, it mayalso be capable of changing the force between an on and off setting, forexample where the “on” setting instantly adjusts to the maximum level offorce required by the orthotic device and the “off” setting instantlyadjusts to zero force sustained by the tensioning device.

In application, the user may require the device to be durable andresistant to environmental wear after years of daily use. Conditions, byexample, include exposure to sand, dirt, water, low temperature (belowfreezing) and high temperature (above 80° F.) periodically or forsustained periods of time. To ensure reliable performance during suchconditions for a lifetime of 5 years or more, the tensioning device inaspects may comprise channels in the housing that allow water and debristo be removed from the internal components of the device during washingor operation of the device. In other aspects, the materials may bedesigned from high-strength, durable plastics or metals that arecorrosion resistant, such as stainless steel.

In aspects, multiple systems to generate mechanical advantage, includingplanetary gears, gear trains and pulleys as described herein may beapplied to generate higher degrees of mechanical advantages and overalldurability.

In aspects, some or all of the components of the tensioning device maybe 3D printed or produced using additive manufacturing methods.

In aspects, different components of the tensioning device can bemodular, such that they can be snapped or assembled into place in or onthe device. Components may be selected based on the orthotic orprosthetic device, the application, or the user's specific needs. Forexample, the number, module or size of gears in the planetary gearsystem can be selected to achieve mechanical advantage between 2:1 and30:1. Additionally, different knob sizes or geometries may be selectedto increase mechanical advantage or improve ergonomics. In aspects, gearsystems, gear trains, and/or pulley systems as described herein may beadded as an internal component of the orthotic or prosthetic device,incorporated into the orthotic or prosthetic's design and fabrication,or may be added as an external modular attachment to provide acompounding mechanical advantage for the device. In aspects, theorthotic or prosthetic device may comprise more than one tensioningdevice, for example in the case of a knee-ankle-foot orthosis thatrequires adjustment of forces around both the knee and ankle joints.

In aspects, the tensioning device may comprise a torque limiting elementto prevent torque overload. In such instances, the tensioning devicewill stop, slip, or disengage when force maintained by the system isabove a specific intended amount. Such a feature may also beintentionally designed into the flexible arm system, in which theflexible arms may disengage by design at forces, for example, above 200lbs. Examples of a torque limiting element include, but are not limitedto friction plates, slip-clutches, shear pins, sprocket and sheavemechanisms, synchronous magnetic torque limiters, ball detents, or pawland spring torque limiters.

In aspects, one or more components of the tensioning device may beelectronic or motorized. In other aspects, the tensioning device mayfurther comprise an additional electronic actuator or motor componentthat winds, unwinds, and/or releases the spool directly or indirectly.For example, the dial component may be paired with a motor, which can becontrolled by the user with a digital interface or mobile device inorder to rotate the dial and increase, decrease or maintain tension inthe orthotic or prosthetic device. In other examples, the electronic ormotorized system may be controlled due to sensory input on the orthoticor prosthetic device or on the user.

In a particular embodiment, an anchor ring (14) and socket (18) lockinggeometry described herein and as shown in FIG. 1 , which uniquelycorresponds to this invention and the orthotic or prosthetic deviceframe in which it is used. The anchor ring can twist into the socketcounter clockwise. When the dial tensioning device is configured totighten when the dial is rotated in a clockwise direction, the anchorring self-tightens into the socket when tension is applied to the spool.Four helical threads are positioned around the outer periphery of theanchor ring. Each thread is 8.5 mm tall, having a generally round crosssection with a diameter of 4 mm, and a pitch of 110 mm. The threads aresymmetrically but not uniformly arranged around the periphery. Eachthread is 60 degrees apart from one neighbor and 120 degrees apart fromthe other neighbor. The inner diameter of the socket is 40 mm. Twofingers on the bottom of the anchor ring deform slightly while theanchor ring is screwed into the socket. When the anchor ring is fullyscrewed in, the fingers click into corresponding depressions in thesocket which prevent the anchor ring from unscrewing. Pins can beinserted into the holes in the depressions to release the fingersthereby allowing the anchor ring to be unscrewed from the socket.

The invention includes the following exemplary embodiments:

An adjustable tensioning device as described herein, wherein the pulleymechanism is built into the orthotic or prosthetic device frame.

The adjustable tensioning device as described herein, further comprisingan electronic or motorized component.

The adjustable tensioning device as described herein, further comprisinga cylindrical clutch with vertical faces that result in a nearly flatrelease force that is independent of the lace tension.

The adjustable tensioning device as described herein, further comprisinga spool reinforced with metal dowel pins that act as the pivots for theplanetary gears and prevent the lace from cutting the spool shaft.

The adjustable tensioning device as described herein, further comprisingan anchoring element removably attached to a corresponding socket,wherein the anchoring element is stationary relative to thecorresponding socket when tension is applied to the spool.

The adjustable tensioning device as described herein, wherein theanchoring element is lockable.

The adjustable tensioning device as described herein, wherein a sun gearof the planetary gear mechanism has 17 or less teeth; wherein planetarygears of the planetary gear mechanism have six or more teeth; wherein acombination of the sun gear, the planetary gears, and ring gear, providea torque ratio of at least three-to-one; and wherein the combination ofthe sun gear, the planetary gears, and the ring gear, generate at least50 pounds of tension in the tensioning element.

The adjustable tensioning device as described herein, wherein a gearmodule is comprised of the combination of the sun gear and the planetarygears, and wherein the gear module is about 1.2, the gear height isabout 5 mm, and at least one of the sun gear or the planetary gears aremade of nylon material.

The adjustable tensioning device as described herein, wherein theanti-unspooling mechanism comprises a system of sprags that stop orlimit backlash of the tensioning element, wherein the system of spragscan be released by pressing or rotating the rotatable knob, the releasecaused by the rotatable knob pushing the sprags of the system of spragsopen simultaneously, thereby allowing the spool to unwind the tensioningelement.

The adjustable tensioning device as described herein, wherein the spoolcomprises a pass-through hole allowing tension in the tensioning elementto be balanced between both sides of the spool.

The adjustable tensioning device as described herein, wherein dogs orpawls are integrated within the carriage of the planetary gearmechanism.

The adjustable tensioning device as described herein, wherein one ormore components are 3D printed.

The adjustable tensioning device as described herein, wherein theadjustable tensioning device is modular, and wherein components areselected or added based on the specific orthotic or prosthetic device,application, or user need.

The adjustable tensioning device as described herein, further comprisingan electronic or motorized component.

The adjustable tensioning device as described herein, wherein the devicecomprises modular components and can be customized to the specificorthotic or prosthetic device, user need, or application through digitaldesign or selection of the modular components during the fabricationprocess.

While the various embodiments of the tensioning device are described inorthotic and prosthetic devices by example, one skilled in the art willrecognize that the same mechanism and features may be applied in otheruse applications for winding, releasing, and tensioning inelastic orsemi-inelastic cable or lace. Such examples include force adjustment inexercise devices, fishing reels, medical device strapping and fitmentsystems, posture corrective devices, rehabilitative equipment, helmets(including bicycle, military, and athletic helmets), apparel,exoskeletons, pulley systems, and personal protective equipment. Thetensioning device may be used in orthotic devices for any joint or bodypart in order to adjust forces around, between, or within the joint orbody part including the knee, ankle, foot, shoulder, elbow, wrist, hand,back, neck, and hip.

One skilled in the art will recognize that the disclosed features may beused singularly, in any combination, or omitted based on therequirements and specifications of a given application or design. Whenan embodiment refers to “comprising” certain features, it is to beunderstood that the embodiments can alternatively “consist of” or“consist essentially of” any one or more of the features. Otherembodiments of the invention will be apparent to those skilled in theart from consideration of the specification and practice of theinvention.

It is noted that where a range of values is provided in thisspecification, each value between the upper and lower limits of thatrange is also specifically disclosed. The upper and lower limits ofthese smaller ranges may independently be included or excluded in therange as well. The singular forms “a,” “an,” and “the” include pluralreferents unless the context clearly dictates otherwise. It is intendedthat the specification and examples be considered as exemplary in natureand that variations that do not depart from the essence of the inventionfall within the scope of the invention. Further, all the referencescited in this disclosure are each individually incorporated by referenceherein in their entirety and as such are intended to provide anefficient way of supplementing the enabling disclosure of this inventionas well as provide background detailing the level of ordinary skill inthe art. It is noteworthy that in certain embodiments, the reference toan aircraft is utilized. However, such embodiments can be utilized forall types of vehicles where multiple seated individuals are seated onebehind the other. It is noteworthy that in certain embodiments thereference to a theater is utilized. However, such embodiments can beutilized for all types of theaters where multiple seated individuals areseated one behind the other.

Although various features of the invention may be described in thecontext of a single embodiment, the features may also be providedseparately or in any suitable combination. Conversely, although theinvention may be described herein in the context of separate embodimentsfor clarity, the invention may also be implemented in a singleembodiment.

As used herein, the term “about” refers to plus or minus 5 units (e.g.,percentage) of the stated value.

Reference in the specification to “some embodiments”, “an embodiment”,“one embodiment” or “other embodiments” means that a particular feature,structure, or characteristic described in connection with theembodiments is included in at least some embodiments, but notnecessarily all embodiments, of the inventions.

“Attachable” as used herein can mean releasably attachable, such as acomponent that can be attached and then detached, or a component that isattached and remains attached.

As used herein, the term “substantial” and “substantially” refers towhat is easily recognizable to one of ordinary skill in the art.

It is to be understood that the phraseology and terminology employedherein is not to be construed as limiting and are for descriptivepurpose only.

It is to be understood that the details set forth herein do not construea limitation to an application of the invention.

Furthermore, it is to be understood that the invention can be carriedout or practiced in various ways and that the invention can beimplemented in embodiments other than the ones outlined in thedescription above.

It is to be understood that the terms “including,” “comprising,”“consisting” and grammatical variants thereof do not preclude theaddition of one or more components, features, steps, or integers orgroups thereof and that the terms are to be construed as specifyingcomponents, features, steps or integers.

What is claimed:
 1. An adjustable tensioning device comprising: arotatable dial, wherein rotating the rotatable dial causes a spool toturn and a tensioning element to wind around the spool, wherein thespool is configured to store four or more inches of the tensioningelement; a torque multiplying system that increases the force applied tothe tensioning element wound around the spool, wherein the torquemultiplying system is capable of increasing the force applied to thetensioning element by three times or more; an anti-unspooling mechanismto prevent the tensioning element from unwinding from the spool when atension acting on the spool is 50 pounds or more; and a clutch thatcouples and decouples the rotatable dial from the spool.
 2. Theadjustable tensioning device of claim 1, wherein the torque multiplyingsystem comprises at least one of a cycloidal gear mechanism, a geartrain, a worm gear drive, and a planetary gear mechanism.
 3. Theadjustable tensioning device of claim 2, wherein a carriage of theplanetary gear mechanism holds planetary gears of the planetary gearmechanism both below a bottom face and above a top face of the planetarygears.
 4. The adjustable tensioning device of claim 1, wherein theclutch comprises two elements, a first element comprising a plurality ofprotrusions, and a second clutch element comprising a plurality ofrecesses, wherein the plurality of protrusions of the first clutchelement intermesh with the plurality of recesses of the second clutchelement, wherein the plurality of protrusions have protrusion faces, andwherein the protrusion faces are configured to substantially align withan axial motion of the first clutch element in relation to the secondclutch element.
 5. The adjustable tensioning device of claim 4, whereinthe second clutch element is moveable with respect to the first clutchelement from a first position, wherein the protrusions of the firstclutch element intermesh with the plurality of recesses of the secondclutch element, to a second position, wherein the protrusions of thefirst clutch element do not intermesh with the plurality of recesses ofthe second clutch element, wherein changing from the first position tothe second position is performed using a push button.
 6. The adjustabletensioning device of claim 1, wherein the clutch comprises a firstclutch element and a second clutch element, wherein the poolingmechanism is coupled to at least one of the first clutch element or thesecond clutch element, and wherein the spool is coupled to the secondclutch element.
 7. The adjustable tensioning device of claim 1, whereinthe anti-unspooling mechanism is configured to act indirectly on thespool, such that when the clutch is disengaged only the spool unwindsthe tensioning element.
 8. The adjustable tensioning device of claim 1,wherein the adjustable tensioning device is a component of a medicaldevice, and the adjustable tensioning device is used to adjust forcesaround, across, or between a joint or a body part being treated by themedical device.
 9. The adjustable tensioning device of claim 1, furthercomprising an anchoring element, wherein the anchoring element comprisesa plurality of flexible arms, and wherein the plurality of flexible armsare integrated with the anchoring element in a single solid member. 10.The adjustable tensioning device of claim 1, wherein the rotatable dialis at least one of a knob, a lever, a ratchet, a handle, or a crank,that can be engaged to increase tension on the tensioning element. 11.The adjustable tensioning device of claim 1, wherein the spool includesa bottom flange and a top flange, wherein the bottom flange provides aslot in engagement with a tensioning element path in the spool, whereinthe slot is offset angularly from the tensioning element path forinsertion and securing of the tensioning element.
 12. The adjustabletensioning device of claim 1, wherein the rotatable dial and spool havedifferent diameter sizes, and wherein the different diameter sizesbetween the rotatable dial and the spool create a mechanical advantagesuch that a lever arm of the rotatable dial is greater than a lever armof a shaft of the spool.
 13. The adjustable tensioning device of claim1, wherein the spool includes a spool shaft, a bottom flange, and a topflange, wherein one or more reinforcement structures are located withinthe spool and oriented perpendicular to the bottom flange and the topflange and parallel to the spool shaft.
 14. The adjustable tensioningdevice of claim 1, wherein the tensioning element further comprises anenergy storage element, wherein the energy storage element exerts avariable tension or compression force that is modulated by theadjustable tensioning device, and wherein the energy storage element isat least one of a spring, an elastomer, a pneumatic mechanism, ahydraulic mechanism, or a magnetic mechanism.
 15. The adjustabletensioning device of claim 1, further comprising at least one of matingrecesses of the anti-unspooling element, flexible arms, a ring gear ofthe torque multiplying mechanism, a recess of an axial boss of thespool, a tensioning element path, and a retaining lip upon which therotatable dial is clipped and rotates around, wherein the at least oneof the mating recesses of the anti-unspooling element, the flexiblearms, the ring gear of the torque multiplying mechanism, the recess ofthe axial boss of the spool, the tensioning element path, and theretaining lip, are produced continuously with a component or a frame ofan orthotic or prosthetic device.
 16. The adjustable tensioning deviceof claim 1, wherein the torque multiplying system comprises a system ofpulleys and holds for multiplying a mechanical advantage on thetensioning element from a first end of the system of pulleys and holdsto a second end of the system of pulleys and holds.
 17. The adjustabletensioning device of claim 1, wherein the torque multiplying systemcomprises a pulley system, wherein the tensioning element traverses atleast one fixed pulley and at least one moveable pulley to generate amechanical advantage.
 18. The adjustable tensioning device of claim 1,further comprising a release mechanism, wherein the release mechanismcomprises embedded magnets to hold the clutch in an engaged position ora disengaged position.
 19. The adjustable tensioning device of claim 18,wherein the release mechanism is a push button, wherein the push buttonis configured to remain in the disengaged position once pushed downuntil the rotatable dial is rotated, the rotating causing the pushbutton to release to the engaged position.
 20. An adjustable tensioningdevice comprising: a rotatable dial, wherein rotating the rotatable dialcauses a spool to turn and a tensioning element to wind around thespool, wherein the spool is configured to store four or more inches ofthe tensioning element; a torque multiplying system that increases theforce applied to the tensioning element wound around the spool, whereinthe torque multiplying system is capable of increasing the force appliedto the tensioning element by three times or more, wherein the torquemultiplying system comprises a pulley system, wherein the tensioningelement traverses at least one fixed pulley and at least one moveablepulley to generate a mechanical advantage; an anti-unspooling mechanismto prevent the tensioning element from unwinding from the spool when atension acting on the spool is 50 pounds or more; and a clutch thatcouples and decouples the rotatable dial from the spool.
 21. Theadjustable tensioning device of claim 20, wherein the clutch comprisestwo elements, a first element comprising a plurality of protrusions, anda second clutch element comprising a plurality of recesses, Wherein theplurality of protrusions of the first clutch element intermesh with theplurality of recesses of the second clutch element, wherein theplurality of protrusions have protrusion faces, and wherein theprotrusion faces are configured to substantially align with an axialmotion of the first clutch element in relation to the second clutchelement.
 22. The adjustable tensioning device of claim 20, wherein theanti-unspooling mechanism is configured to act indirectly on the spool,such that when the clutch is disengaged only the spool unwinds thetensioning element.
 23. The adjustable tensioning device of claim 20,wherein the clutch comprises a first clutch element and a second clutchelement, wherein the anti-unspooling mechanism is coupled to at leastone of the first clutch element or the second clutch element, andwherein the spool is coupled to the second clutch element.
 24. Theadjustable tensioning device of claim 20, wherein the adjustabletensioning device is a component of a medical device, and the adjustabletensioning device is used to adjust forces around, across, or between ajoint or a body part being treated by the medical device.
 25. Theadjustable tensioning device of claim 20, further comprising ananchoring element, wherein the anchoring element comprises a pluralityof flexible arms, and wherein the plurality of flexible arms areintegrated with the anchoring element in a single solid member.
 26. Theadjustable tensioning device of claim 20, wherein the rotatable dial isat least one of a knob, a lever, a ratchet, a handle, or a crank, thatcan be engaged to increase tension on the tensioning element.
 27. Theadjustable tensioning device of claim 20, wherein the tensioning elementfurther comprises an energy storage element, wherein the energy storageelement exerts a variable tension or compression force that is modulatedby the adjustable tensioning device, and wherein the energy storageelement is at least one of a spring, an elastomer, a pneumaticmechanism, a hydraulic mechanism, or a magnetic mechanism.
 28. A medicaldevice for adjusting force on, across, between, within, or around a limbor a joint, the medical device comprising: a rotatable dial or leverthat gathers tension with rotation; a spool directly or indirectlycoupled to the rotatable dial or lever, wherein a tensioning element canbe wound around the spool; a tension locking system comprising of asystem of pawls and holds; a torque multiplying system; and a mechanismfor disengaging the spool thereby allowing the tensioning element tounwind from around the spool.
 29. A method for adjusting an amount offorce on, across, between, within, or around a limb or a joint of awearer of an orthotic, the amount of force applied by the orthotic, themethod comprising: a wearer of the orthotic rotating a dial or lever onthe orthotic to increase the amount of force on, across, between,within, or around the limb or the joint of the wearer; rotation of thedial or lever causing a tensioning element to wind around a spool,thereby increasing tension on the tensioning element and increasing theamount of force on, across, between, within, or around the limb or thejoint of the wearer; locking the spool in place using a tension lockingsystem comprising a system of pawls and holds; and unlocking the spoolby engaging the dial or the lever, thereby releasing tension on thetensioning element and decreasing the amount of force on, across,between, within, or around the limb or the joint of the wearer; whereinthe wearer can adjust the amount of force while the wearer is wearingthe orthotic.